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Clinical Trial With MSC for Graft Versus Host Disease Treatment

Primary Purpose

Acute Graft Versus Host Disease

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Adult Allogeneic Mesenchymal cells from adipose tissue.

About this trial

This is an interventional treatment trial for Acute Graft Versus Host Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
Having been transplanted with myeloablative or non-myeloablative conditioning.
normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
Lung function without evidence of severe obstructive or restrictive lung disease.
Age between 18 and 65 years.
Women of childbearing age considered until one year after the last menstrual period and which have not undergone a surgical sterilization must obtain a negative pregnancy test at the time of inclusion in the study and commit to use a medically approved birth control while on study.
normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
Signature of informed consent -

Exclusion Criteria:

uncontrolled blood disorder by transplantation or progression at the time of inclusion.
bacterial, viral, fungal or is not being controlled.
Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -

Sites / Locations

Clinica Universitaria de Navarra, Av Pio XII ,36
Hospital Universitario Reina Sofía
Hospital Clínico Universitario Virgen de la Arrixaca
Hospital Regional Universitario de Málaga
Hospital clinico universitario de salamanca
Virgen del Rocio University Hospital, av. Manuel Siurot s/n

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeneic Mesenchymal Cells

Arm Description

All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group.

Outcomes

Primary Outcome Measures

Safety measured by incidence of serious adverse events

Safety will be measured in terms of: Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.

Secondary Outcome Measures

Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment

Effectiveness will be measured in terms of: Answer of refractory acute graft disease against host to first-line treatment

Full Information

NCT ID

NCT02687646

First Posted

January 19, 2016

Last Updated

October 10, 2022

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

Andalusian Initiative for Advanced Therapies

1. Study Identification

Unique Protocol Identification Number

NCT02687646

Brief Title

Clinical Trial With MSC for Graft Versus Host Disease Treatment

Official Title

Clinical Trial Phase I / II Graft Versus Host Disease Treatment Refractory to First-line Therapy With Sequential Infusion of Mesenchymal Cells Allogeneic Expanded Adipose Tissue in Vitro

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

February 20, 2017 (Actual)

Primary Completion Date

January 21, 2022 (Actual)

Study Completion Date

January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

Andalusian Initiative for Advanced Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.

Detailed Description

Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell trasplantation, who have developed a refractory graft versus host disease to first line of treatment. This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Graft Versus Host Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allogeneic Mesenchymal Cells

Arm Type

Experimental

Arm Description

All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group.

Intervention Type

Drug

Intervention Name(s)

Adult Allogeneic Mesenchymal cells from adipose tissue.

Other Intervention Name(s)

MSC for the treatment of graft -versus -host disease

Intervention Description

Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products. Subjects will receive four sequential IV dose of Mesenchymal stem cells. Sequential doses: Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg

Primary Outcome Measure Information:

Title

Safety measured by incidence of serious adverse events

Description

Safety will be measured in terms of: Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment

Description

Effectiveness will be measured in terms of: Answer of refractory acute graft disease against host to first-line treatment

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment. Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor. Having been transplanted with myeloablative or non-myeloablative conditioning. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process Lung function without evidence of severe obstructive or restrictive lung disease. Age between 18 and 65 years. Women of childbearing age considered until one year after the last menstrual period and which have not undergone a surgical sterilization must obtain a negative pregnancy test at the time of inclusion in the study and commit to use a medically approved birth control while on study. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process. Signature of informed consent - Exclusion Criteria: uncontrolled blood disorder by transplantation or progression at the time of inclusion. bacterial, viral, fungal or is not being controlled. Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures. Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period. Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time. positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresa Caballero, Hematologist

Organizational Affiliation

Virgen del Rocio University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Clinica Universitaria de Navarra, Av Pio XII ,36

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital Universitario Reina Sofía

City

Córdoba

Country

Spain

Facility Name

Hospital Clínico Universitario Virgen de la Arrixaca

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Hospital Regional Universitario de Málaga

City

Málaga

Country

Spain

Facility Name

Hospital clinico universitario de salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Virgen del Rocio University Hospital, av. Manuel Siurot s/n

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Clinical Trial With MSC for Graft Versus Host Disease Treatment

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